Site Activation Partner I – FSP, Fixed-Term 7 months

Parexel

. Lead or support operational activities from study start-up through close-out for assigned studies and investigator sites .

Posted 9/18/2026contractRemote • Mexico, Argentina, BrazilMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical site management and regulatory compliance, with a strong understanding of clinical trial methodologies and ICH/GCP standards. Proficient in managing study documents and coordinating site activation processes while ensuring effective communication with stakeholders.

Highest-signal resume keywords

Clinical Site ManagementRegulatory Document SubmissionICH/GCP KnowledgeStudy Activation CoordinationFluency in English and Local Language

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MethodologiesRegulatory ComplianceDocument ManagementSite Activation ProcessesClinical Research KnowledgeQuality Review and AuditsMultitaskingAttention to DetailBasic Medical TerminologyComputer Operations

Soft Skills

Effective CommunicationTeam CollaborationOrganizational SkillsProblem-SolvingIndependent Work

Industry Keywords

FDA RegulationsCRO ExperienceInvestigator Initiation PackagesTrial Master FileEthics Committee ApprovalsSite Compliance TrackingMultilanguage CapabilityClient SOPsStudy Point of ContactGlobal Initiative Representation

About the role

Key responsibilities & impact

Lead or support operational activities from study start-up through close-out for assigned studies and investigator sites
Initiate and coordinate activities and essential document management for Investigator Initiation Packages and site activation
Register and maintain investigator sites and client stakeholders in client registries and systems
Interact with investigator sites to confirm start-up readiness and review site profiles, essential documents, contracts, supplies, payments, and IRB information
Resolve and escalate site issues within required timelines
Prepare, validate, and submit regulatory documents for internal approval
Coordinate supporting roles and activities to ensure timely site activation
Support Central and local IRB/Ethics Committee packages, submissions, communications, and approvals
Assist with non-clinical trial supplies, tracking, clinical documentation, filing, and archiving
Support electronic Investigator Site File readiness and manage access before Site Initiation Visits
Coordinate in-scope document translations
Manage study documents and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and annual Ethics Committee approvals
File documents to the Trial Master File and support quality reviews and audits/inspections
Maintain clinical trial systems tracking site compliance and performance
Communicate study, country, and site updates, approvals, issues, delays, and escalations to stakeholders
Provide site personnel awareness sessions on client requirements and compliance
Complete assigned training and adhere to EP and client SOPs and processes
Learn and potentially implement site activation processes across more than one country
Potentially serve as study Point of Contact, Subject Matter Expert, global initiative representative, or mentor

Requirements

What you’ll need

At least 2 years of experience in start-up working with US/Canada
Minimum 3 years’ relevant experience in clinical site management, working with US/Canada
School diploma/certificate with equivalent combination of education, training and experience
Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations
Effective verbal and written communication skills
Good technical skills and ability to learn and use multiple systems
Knowledge of clinical research and development processes and key operational elements of a clinical trial
Ability to understand quality expectations and demonstrate compliance with company, regulatory, and country requirements
Attention to detail and disciplined approach
Ability to work independently and as a team member
Ability to organize tasks, time, and priorities and multitask
Understanding of basic medical terminology and GCP requirements
Proficient in computer operations
Fluency in the local language and English
Bachelor of Science, Bachelor of Arts, or Bachelor’s in Life Sciences preferred
Experience working in the pharmaceutical industry or CRO in study site activation preferred
Multilanguage capability preferred

Benefits

Comp & perks

Potential to transition into a full-time role after the 7-month temporary assignment
Client- and EP-provided training, including general training requirements, SOPs, system and process-related training
Potential mentoring and subject matter expert opportunities
Participation in global initiatives
Opportunity to support mentoring of new hires